Function of Circulating Exosomes in Sepsis-induced Immuno... | NCT04979767

Studies
Function of Circulating Exosomes in Sepsis-induced Immunosuppression

NCT04979767

Sponsor

University of Kansas Medical Center

Status

Unknown status

Last Update Posted

Jul 28, 2021Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Sepsis
Septic Shock
Sepsis Syndrome
Sepsis Bacterial
Sepsis, Severe
Sepsis Bacteremia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2021Actual

Primary Completion Date

Oct 31, 2021Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

May 14, 2021

First Submission Date that Met QC Criteria

Jul 16, 2021

First Posted Date

Jul 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2021

Last Update Posted Date

Jul 28, 2021Actual

Name	Class
University of Kansas	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis		I. ≥ 50 years with ≥ 2 chronic comorbidities II. Highly suspected bacterial infection based on clinical or radiologic evidence III. ≥ 2 systemic inflammatory response syndrome (SIRS) criteria IV. Actual/anticipated admission to intensive care unit (ICU) V. Anticipated length of hospital stay ≥ 5 days
Control		I. ≥ 50 years with ≥ 2 chronic comorbidities II. No suspected bacterial infection III. Actual/anticipated admission to intensive care unit (ICU) IV. Anticipated length of hospital stay ≥ 5 days

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day mortality	All-cause mortality	From enrollment to 28 days

Secondary Outcomes

Measure	Description	Time Frame
Hospital mortality	All-cause mortality	From enrollment until hospital discharge, up to 90 days
90-day mortality	All-cause mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 50 years with ≥ 2 chronic comorbidities
Highly suspected bacterial infection based on clinical or radiologic evidence
≥ 2 systemic inflammatory response syndrome (SIRS) criteria
Actual/anticipated admission to intensive care unit (ICU)
Anticipated length of hospital stay ≥ 5 days

Exclusion Criteria:

Pregnancy
Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
Current immunotherapy use
Confirmed COVID-19 infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospitalized adult patients admitted to the intensive care unit with sepsis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luigi R Boccardi, BS	Contact	913-588-4022		lboccardi@kumc.edu
Vaughn D Craddock, BS	Contact	316-708-7352		vcraddock2@kumc.edu

Overall Officials

Name	Affiliation	Role
Nicholas S Britt, PharmD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center	Recruiting	Kansas City	Kansas	66160	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic
D018746	Systemic Inflammatory Response Syndrome

Ancestor Terms

ID	Term
D007239	Infections
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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